APPLICATION
NDA019407
TYPE
NDA
ORIGINAL APPROVAL
1989-03-31
LATEST ACTION
2002-11-01
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter
Products
VISINE L.R. · ReferenceOver-the-counter
OXYMETAZOLINE HYDROCHLORIDE 0.025% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-01-11Manufacturing (CMC) · Supplement 9 · standardAP
2000-02-10Manufacturing (CMC) · Supplement 8 · standardAP
1999-10-15Manufacturing (CMC) · Supplement 7 · standardAP
1998-03-17Manufacturing (CMC) · Supplement 6 · standardAP
1998-03-05Manufacturing (CMC) · Supplement 5 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 4 · standardAP
1990-02-13Manufacturing (CMC) · Supplement 2 · standardAP
1989-10-27Labeling · Supplement 1AP
1989-03-31Type 5 - New Formulation or New Manufacturer · Original · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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